Research Associate

Job Category:  Scientific

Location: Waltham, MA

Duration: 12 Months 0 weeks.

Pay Rate: $38/hr on w2

Description:

• The Genetic Medicine Unit CMC organization is responsible for the design and optimization of viral vector and cell therapy manufacturing processes and platforms. A key function of this group is to establish operational excellence in the manufacturing of  emerging portfolio of gene therapy products, supported by a diverse panel of analytical methods to provide process understanding and product characterization.
• The BioProcess Analytics support group located in Waltham, MA is responsible for execution of analytical methods to support manufacturing and development activities, building process understanding, and supporting life cycle management from early to late stage clinical entry. The Research Associate (Analytical Technician) is responsible for executing test methods under control of established procedures. We are looking for a candidate that has experience in an analytical setting that can independently manage and execute their testing schedule supportive of genomic medicines process development. In addition, they should possess the skills to interpret and communicate their data with the appropriate development teams.

Key Responsibilities:

• Execute test methods following established procedures.
• Life cycle management of established procedures
• Work with Process Development groups to design testing packages around studies targeting key information.
• Manage testing and training deliverables against defined schedules.
• Maintain all documentation and reports, including assay documentation, training folders and assay databases.
• Contribute to assay investigations for out of expectation results or test failures, working with manager and customers on root cause analysis and mitigation strategies.
• Lead or support assay transfers as part of a cross functional team
• Support maintenance of facility infrastructure and management of inventories for assay
• supplies, reagents, controls and standards.
• Perform data analyses and contribute to technical reports, protocols and
• internal/external presentations
• Attendance at GMU and inter-departmental meetings and work streams as needed.
• Potential for occasional weekend and holiday work to support ongoing lab activities.

 Qualifications:

• BS in biological sciences or related field with 0-3 years of relevant experience
• biotechnology or pharmaceutical industry.
• Experience in an analytical setting and executing assays relevant to qPCR and cell culture.
• Excellent organization and documentation skills, committed to internal documentation practices.

Required Skills
Protein biomarker research - design, validation, and implementation of protein immunoassays:
Meson Scale Discovery, ELISA, bead based Simoa, Simple Western, Isoplexis etc.
? Experience in handling biological materials (tissues, tumors, blood samples, CSF, etc.).
? Cell culture experience preferred
? Lab automation (liquid handling workstations, plate washers).
? Good knowledge of scientific data analysis, graphing, and curve fitting software (Excel, GraphPad Prism, TIBCO Spotfire).
? Strong organizational and analytical skills; attention to detail is critical.
? Ability to write technical reports describing experiments and their outcome.

Must Have:

• QPCR • Mammalian cell culture • Professional 6+ months of professional work experience (post-graduation), *some school experience may be counted towards this requirement • Assay, bio assay, Micobiolecual biology • MS Office Skills • Self Motivated & Strong communication skills

Nice to Have:

• Preferred R&D Professional Pharma Experience (preferred) • characterize Adenovirus and Adeno-Associated Virus vectors • Internal documentation, self-motivation, hark • ddPCR • Automation technology platforms Ex: Integ Assist, Biomek

Shift: Day